The National Assembly finally passed the "Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals," this year. Also, the government has implemented the Medical Device Development and Innovative Medical Device Act, which were both long-awaited legislation for the medical device industry. The industry expects the recently passed laws will give them a new footing for them to leap forward in the sector.
The Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals, passed by the National Assembly in August, manages biopharmaceuticals and regenerative medicines, which have different characteristics from existing generic drugs, separately. Countries such as the United States and Japan have passed similar legislation to track and manage such medicines.
The main contents of the legislations include priority screening of biopharmaceuticals treating rare diseases, step-by-step preliminary screening tailored to the developer, and conditional approval to expand treatment opportunities for medications that have proven its efficacy. The law will take effect from Aug. 28 next year.
Notably, the pharmaceutical industry is focusing on the rapid screening of advanced biopharmaceuticals.
The system is primarily composed of three parts -- customized screening, priority screening, and conditional licensing.
Customized screening is a pre-screening that allows developers to submit their permission and review data in advance according to their schedule. It is expected that the process will shorten the nonclinical and clinical period.
Priority screening prioritizes advanced biopharmaceuticals over other drugs. While new drug screenings previously took about 115 days, the new priority screening process is expected to shorten the period by less than 100 days.
Conditional licensing is designed to provide faster treatment opportunities for patients who do not have a treatment. It grants conditional marketing approval for companies that have completed phase 2 clinical trials for a specific drug while planning to conduct phase 3 clinical trials after receiving the sales approval.
Government and industry officials predicted that if all three processes of expedited screening were applied, companies would be able to decreased drug development from the current 12 to 15 years to 3.5 to 4.5 years.
Injecting cells into the patient to treat the disease is limited, however.
Also, the passage of advanced regenerative medicine has provided the basis for clinical research such as cell, gene, and tissue engineering therapy. The new regulation will allow limited cell injection to treat illnesses in patients.
So far, the treatments have only received approval after they proved their safety and efficacy through the clinical trial process according to the pharmacological method. As a result, some patients with rare or incurable diseases have been paying tens of thousands of dollars to go to Japan to receive regenerative medicine treatment.
However, civic groups had opposed regenerative medicine after raising concerns about the safety of the treatment, including lack of clinical efficacy.
In this regard, regulators have strengthened the safety management of clinical trials in the new regulation. Companies wanting to conduct advanced research on regenerative medicine will have to receive a review from the National Regenerative Medical Review Committee on the feasibility and necessity of the clinical research plan and measures to secure patient safety.
The National Regenerative Medical Review Committee consists of up to 20 medical practitioners, researchers and ethics experts, and patient advocates.
If there is a need for investigation of abnormal cases for a certain period after the administration of stem cell and animal cell-derived products, the drug will be designated as a subject for a long-term follow-up investigation, which will be conducted by the Regulatory Science Center.
The center will provide long-term follow-up of advanced biopharmaceuticals and information and technology support. The Ministry of Food and Drug Safety can either establish the center or designate an institution.
In April, the National Assembly also passed the Medical Device Development and Innovative Medical Device Act during its plenary session.
The act certifies companies that actively invest in R&D for innovative medical devices and grant preferential R&D projects, support for research facility construction, and exemption of various taxes.
Also, it designates medical devices that have significantly improved safety and effectiveness compared to existing medical devices as innovative medical devices and supports rapid commercialization, such as priority screening.
The legislation also introduced a certification system for innovative medical device software, which allows companies to exempt the duplication of data such as manufacturing and quality management system evaluation data upon approval, while improving the procedure to carry out clinical trials with the approval of the clinical trial review committee.
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